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FDA 510(k)

ScanX Swift 2.0, ScanX Swift View 2.0

K-Number: K230095 · 2023-02-06

Decision Date2023-02-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ScanX Swift 2.0, ScanX Swift View 2.0 is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2023-02-06 under approval number K230095. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScanX Swift 2.0, ScanX Swift View 2.0?

ScanX Swift 2.0, ScanX Swift View 2.0 is a medical device that received FDA 510(k) clearance on 2023-02-06. It is manufactured by Durr Dental SE. The 510(k) number is K230095.

When was ScanX Swift 2.0, ScanX Swift View 2.0 approved by the FDA?

ScanX Swift 2.0, ScanX Swift View 2.0 received FDA 510(k) clearance on 2023-02-06, under approval number K230095.

What company makes ScanX Swift 2.0, ScanX Swift View 2.0?

ScanX Swift 2.0, ScanX Swift View 2.0 is manufactured by Durr Dental SE.

What is the FDA product code for ScanX Swift 2.0, ScanX Swift View 2.0?

The FDA product code for ScanX Swift 2.0, ScanX Swift View 2.0 is MUH.

Other Devices by Durr Dental SE

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Related Devices (Code: MUH)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.